MAUDE Adverse Event Report: ARTHREX, INC. DEPTH GUIDE, MINI; DEPTH GAUGE

Model Number	DEPTH GUIDE, MINI
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/16/2023, it was reported by a sales representative via sems that an ar-13120g-2 mini depth guide was bent and missing the hook.This was discovered during an unspecified time with no patient effect.
Additional Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint is confirmed.One unpackaged ar-13120g-2 serial/batch number (b)(6) was received for investigation.No functional test for this device with a bent shaft and tip, and the tip was broken off.Visual evaluation noted that the instrument shaft and tip were bent; additionally, the hook tip was broken off.The most likely cause for the reported failure is user error for applying excessive force during use.

• Brand Name: DEPTH GUIDE, MINI
• Common Device Name: DEPTH GAUGE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: emily shafer ; 8009337001
• MDR Report Key: 17270438
• Report Number: 1220246-2023-07066
• Device Sequence Number: 15424284
• Product Code: HTJ
• UDI-Device Identifier: 00888867007727
• UDI-Public: 00888867007727
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DEPTH GUIDE, MINI
• Device Catalogue Number: AR-13120G-2
• Device Lot Number: 1489082304
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown